Phase III Study of Icotinib Treat the Patient With Brain Metastasis EGFR-mutant Non Small Cell Lung Cancer Comparing With Whole Brain Radiotherapy
Patient who was confirmed stage IV NSCLC with EGFR activating mutation and brain
metastases by pathologic histology or cytology.
Patient who brain metastases was shown in MRI or CT scan. Brain metastases lesions should
be more than 3.The diameter among these lesions should be more than 1 centimeter.
Males or females aged ≥18 years, < 75 years. Eastern Cooperative Oncology Group(ECOG)
performance status 0-1. Life expectancy ≥12 weeks. The therapy of
surgery,chemotherapy,radiotherapy that the patients were ever received should be more
than 2 weeks ago.The patient had recovered from the treatment.
Males and females should be contraceptive during the period of the trial until 8 weeks
after the last administration of icotinib.
Able to comply with the required protocol and follow-up procedures, and able to receive
Written informed consent provided.
Patient was received irradiation of brain. Patient with meningeal metastases were
confirmed by MRI or cytology test of cerebrospinal fluid.
Patient is received the treatment of Phenytoin, carbamazepine, rifampicin, phenobarbital,
or St. John's Wort.
Patient was received EGFR Tyrosine Kinase Inhibitor or EGFR monoclonal antibody.
Interstitial pneumonia.Pericardial effusion, pleural effusion is uncontrolled .
Any unstable systemic disease (including active infection, uncontrolled hypertension,
unstable angina, congestive heart failure, myocardial infarction within the previous year,
serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
Any significant ophthalmologic abnormality ,especially severe dry eye syndrome
,keratoconjunctivitis sicca,Sjogren syndrome,severe exposure keratitis or any other
disorder likely to increase the risk of corneal epithelial lesions.
Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome,
or inability to take oral medication, or have active peptic ulcer disease.
Female subjects should not be pregnant or breast-feeding. Adequate hematological function:
Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L.
Adequate renal function: Serum creatinine ≤ 1.5 x ULN, or ≥ 50 ml/min. Adequate liver
function :Total bilirubin £ 1.5 x upper limit of normal (ULN) and Alanine Aminotransferase
(ALT )and Aspartate Aminotransferase (AST )< 2.5 x ULN in the absence of liver metastases,
or < 5 x ULN in case of liver metastases.
The symptoms of increased intracranial pressure are uncontrolled after dehydration and
Patient need increase irradiation dose after routine irradiation(30GY/10f/2w) Patient
should treat extra cranial lesions first. Patient assessed by the investigator to be
unable or unwilling to comply with the requirements of the protocol.